methylphenidate and exercise in reducing cancer-related fatigue in patients with prostate cancer

Conditions: Prostate Carcinoma

Summary: this phase ii/iii trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. methylphenidate is a type of central nervous system stimulant that can improve cognitive ability, mainly in memory and cognitive function. exercise can improve mood and the physical aspects of cancer-related fatigue. giving methylphenidate in combination with exercise may work better in reducing cancer-related fatigue in patients with prostate cancer.

primary objective: i. to determine if the combination of exercise (ex) plus methylphenidate (mp) is superior to exercise plus placebo in the treatment of cancer-related fatigue (crf) in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12 weeks. secondary objective: i. to determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures. exploratory objectives: i. to identify potential synergistic effects of exercise and methylphenidate in improvement of crf. ii. to explore changes in brain activity by electroencephalography (eeg) in responders (with 4 point or greater change in functional assessment of chronic illness therapy-fatigue \[facit-f\] scores) versus (vs) non-responders to the intervention. outline: patients are randomized to 1 of 4 groups. group i: patients receive methylphenidate orally (po) twice daily (bid) and undergo exercise program consisting of resistance training twice weekly (biw) and walking 15- 40 minutes a day 4 days a week for 12 weeks. group ii: patients receive a placebo po bid and undergo exercise program consisting of resistance training biw and walking 15-40 minutes a day for 4 days a week for 12 weeks. group iii: patients receive methylphenidate po bid and undergo stretching for 4 days a week for 12 weeks. group iv: patients receive a placebo po bid and undergo stretching for 4 days a week for 12 weeks. after completion of study treatment, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks * patient not regularly engaging in moderate aerobic exercise for \>90 minutes/week and/or vigorous aerobic exercise for \>30 minutes/week, and/ or strength training for \>/= 1 day/week * have no clinical evidence of cognitive failure as evidenced by memorial delirium assessment scale score of \</=13 at baseline * be aged 18 years or older * be willing to engage in follow-up telephone calls with a research staff * be willing to participate in the exercise programs * have telephone access so they can be contacted by the research staff * have a hemoglobin level of \>/= 10 g/dl within 2 weeks of enrollment * be able to understand the description of the study and give written informed consent * have a zubrod performance status score of 0 to 2 * seen at an outpatient clinic at md anderson cancer center, its houston area locations (hals) or smith radiation oncology clinic (hhs) exclusion criteria: * have a major contraindication to methylphenidatemp) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician * be currently taking mp, or have taken it within the previous 10 days * be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study * need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine * have glaucoma * have severe cardiac disease (new york heart association functional class iii or iv) * have tachycardia and/or uncontrolled hypertension * be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).